Shnorhavorian Margarett, Doody David R, Chen Vivien W, Hamilton Ann S, Kato Ikuko, Cress Rosemary D, West Michele, Wu Xiao-Cheng, Keegan Theresa H M, Harlan Linda C, Schwartz Stephen M
Department of Urology, Division of Pediatric Urology, University of Washington, Seattle Children's Hospital.
Epidemiology Program, Fred Hutchinson Cancer Research Center, Seattle, WA.
Am J Clin Oncol. 2018 Jun;41(6):581-587. doi: 10.1097/COC.0000000000000327.
Adolescent and young adult (AYA) cancer patients are underrepresented in clinical trials, but the reasons for this phenomenon are unknown.
Questionnaire and medical record data from 515 AYA cancer patients (21 acute lymphocytic leukemia [ALL], 201 germ cell tumor, 141 Hodgkin lymphoma, 128 non-Hodgkin lymphoma, 24 sarcoma) from a population-based study were analyzed. We used multivariable models to determine characteristics associated with patient knowledge of the availability of clinical trials for their cancer. Reasons for not participating in a trial were tabulated.
In total, 63% of patients reported not knowing whether a relevant clinical trial was available, 20% reported knowing that a clinical trial was not available, and 17% reported that a trial was available. Among patients reporting an available trial, 67% were recommended for enrollment. Knowing about the availability of clinical trials was associated with having ALL (odds ratio=2.9, 95% confidence interval=1.1, 7.8). Reporting that a clinical trial was available was positively associated with having ALL, Hodgkin lymphoma, non-Hodgkin lymphoma and sarcoma (relative to germ cell tumor) and working full-time or in school full-time (odds ratio=2.6, 95% confidence interval=1.0, 6.7). Concerns about involvement in research (57%) and problems accessing trials (21%) were the primary reasons cited for not enrolling among patients who knew that a trial was available.
Improvement in AYA cancer patient clinical trial enrollment will require enhancing knowledge about trial availability and addressing this population's concerns about participating in medical research.
青少年及青年（AYA）癌症患者在临床试验中的代表性不足，但其原因尚不清楚。
对一项基于人群的研究中515例AYA癌症患者（21例急性淋巴细胞白血病[ALL]、201例生殖细胞肿瘤、141例霍奇金淋巴瘤、128例非霍奇金淋巴瘤、24例肉瘤）的问卷和病历数据进行分析。我们使用多变量模型来确定与患者对其癌症临床试验可及性的了解相关的特征。列出了不参加试验的原因。
总体而言，63%的患者表示不知道是否有相关临床试验，20%的患者表示知道没有临床试验，17%的患者表示有临床试验。在报告有可用试验的患者中，67%被推荐入组。了解临床试验的可及性与患ALL相关（比值比=2.9，95%置信区间=1.1，7.8）。报告有临床试验与患ALL、霍奇金淋巴瘤、非霍奇金淋巴瘤和肉瘤（相对于生殖细胞肿瘤）以及全职工作或全日制上学相关（比值比=2.6，95%置信区间=1.0，6.7）。在知道有试验的患者中，对参与研究的担忧（57%）和获取试验的问题（21%）是不参加试验的主要原因。
改善AYA癌症患者的临床试验入组情况需要提高对试验可及性的认识，并解决该人群对参与医学研究的担忧。
